.r) faGM3T&m-dRrqqm -l-?wTzin -r* a--l-a tiTjJqf (m !JJ%P7) Indian Standard ----'" IS 10654:2002 ISO 7864:1993 STERILE HYPODERMIC NEEDLES FOR SINGLE USE ( Third Revision) ICS 11.040.20 (3 BIS 2002 BUREAU MANAK OF BHAVAN, 9 IN NEW DIANST SHAH DELHI AN DARDS MARG BAHADUR ZAFAR 110002 June 2002 Price Group 6 Medical Instruments and Disposable Sectional Committee, MHD 12 NATIONAL FOREWORD This Indian Standard (Third Revision) which is identical with ISO 7864 : 1993 `Sterile hypodermic needles for single use' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendations of Medical instruments and Disposable Sectional Committee and approval of Medical Equipment and Hospital Planning Division Council. This standard was first published in 1983. Its first revision was undertaken in 1986 and published as dual number standard to align it with ISO 7864:1984. Second revision was undertaken in 1991 and published as dual number standard to align it with second edition of ISO 7864 brought out in 1988. Third revision of the standard adopts third edition of ISO 7864 brought out in 1993 and major differences in third edition and second edition of ISO 7864 are as follows: a) It specifies the use of needle tubing complying with ISO 9626. Smaller outside diameters, thin and extra-thin-walled types of needle tubing introduced. In order to avoid inhibiting innovation, this standard does not recommend combinations of needle diameter and length. Additional information and guidance have been introduced on needle point geometry and fragmentation properties and the limited number of tests for toxicity has been replaced by an informative annex. It permits the use on package Iabelling of the ISO symbol for `do not re-use', but continues require the written word. to b) c) This standard covers sterile hypodermic needles intended for single use primarily in humans. [t does not give requirements or test methods for freedom from biological hazards because international agreement upon the methodology and the pass/fail criteria is incomplete. Guidance on biological evaluation and tests relevant to hypodermic needles are given in IS 12572 (Part 1) : 1994/ ISO 10993-1 :1992 `Biological evaluation of medical devices: Part 1 Guidance on selection of tests (first revision)' and it is suggested that manufacturers take this guidance into account when evaluating products. Such an evaluation should include the effects of the process whereby the needles are sterilized. However, national regulations may exist in some countries, and these will override the guidance in IS 12572 (Part 1) : 1994/lSO 10993-1:1992, Plastic materials to be used for the construction of needles are not specified as their selection will depend to some extent upon the design, process of manufacture and method of sterilization employed by individual manufacturers. The materials should be compatible with injection fluids. Where Indian Pharmacopoeia or other government may take precedence over this Indian Standard. regulations are legally binding, these requirements Annex A forms an integral part of this standard whereas Annexes B, C and D are for information only. The text of standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following: a) Wherever the words `International read as `Indian Standard'; and Standard' appear referring to this standard, they should be b) Comma (,) has been used as a decimal marker while in Indian Standards, is to use a point (.) as the decimal marker. the current practice (Continued on third cover) IS 10654:2002 ISO 7864:1993 Indian Standard STERILE HYPODERMIC NEEDLES FOR SINGLE USE ( Third Revision) 1 Scope This International S'tandard specifies requirements for sterile hypodermic needles for single use of nominal outside diameters 0,3 mm and 1,2 mm. It does not apply to dental needles. ISO 8601:1988, Data elements and interchange formats -- /formation interchange -- Representation of dates and times. ISO 9626:1991, Stain/ess steel needle tubing for the manufacture of medical devices. 3 Nomenclature 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1."General requirements. ISO 594-2:1991, Conical fittings with a 6 % (Luer) taper for syringes, needies and certain other medicai equipment -- Part 2: Lock fittings. ISO 3696:1987, Water for ana/ytica/ Specification and test methods. /aboratory use -- The nomenclature for components of hypodermic needles for single use is shown in figure 1 together with the designation for length L nomenclature for needle points is shown in figure 2. 4 Cleanliness When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 3(N) lx to 700 ix, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under x 2,5 magnification, the hub socket shall appear free from particles and extraneous matter. 5 Limits for acidity or alkalinity When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared in accordance with annex A shall be within one unit of pH of that of the control fluid. ISO 6009:1992, Hypodermic needles for single use ­ Colour coding for identification. ISO 7886-1 :­1), Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use. 1) To be published, 6 Limits for extractable metals When tested by a recognized microanalytical method, for example by an atomic absorption 1 IS 10654:2002 ISO 7864:1993 method, an extract prepared in accordance with annex A shall, when corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/1 of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0,1 mg/1. ante with ISO 6CX)9 applied to the unit container and/or part of the needle assembly such as the needle hub or the sheath. 9 9.1 Needle Conical hub fitting needle hub 7 Size designation The size of hypodermic needle shall be designated by the following: a) the nominal outside diameter of the needle tube, expressed in millimetres; b) the nominal length of the needle tube, expressed in millimetres. The size shall be referred to as "the designated metric size" and shall be expressed in millimetres. EXAMPLE The conical socket of the hypodermic shall be in accordance with ISO 594-1. If the hub has a locking fitting, it shall be in accordance with ISO 594-2. 9.2 Coiour of hub The hub shall be made either of pigmented or of unpigmented material. If pigmented, the colour shall be in accordance with ISO 6009. 0,8 x 40 8 Colour coding 10 Sheath The nominal outside diameter of hypodermic needles shall be identified by colour coding in accord- If a separate needle sheath is provided, it shail be made either of pigmented or of unpigmented material. If pigmented, the colour shall be in accordance with ISO 6009. Key 1 2 3 4 Hub Jolntlng madlum Needle tube Sheath Figure 1 ­ Example of typical hypodermic needle and sheath for singie use IS 10654:2002 1S0 7864: 1993 Figure 2 -- Designation of dimensions and nomenclature of needle point geometry (see ciause 12) 3 IS 10654:2002 ISO 7864:1993 11 11.1 Needle General tube The needle shall be made of tubing in accordance with ISO 9626. 11.2 Tolerances on length needle points shown are of configurations commonly manufactured: other configurations may be equally satisfactory. It may not be necessary to use all the dimensions when describing the point configuration. The needle point should be designed so as to minimize coreing and fragmentation when penetrating vial closures. This International Standard does not specify requirements or test methods for these properties, but an example of a test method for determining the production of fragments from rubber closures is given in annex B. The actual length of the needle tube (see dimension /in figure 1) shall equal the nominal length within the tolerances given in table 1. Table 1 ­ Tolerances on length of needle tube Dimensions in miilimetres 13 13.1 Performance Bond between hub and needle tube Nominal length of needle tube <25 25 to Tolerence +1 -2 39 +1,5 -2,5 The union of the hub and needle tube shall not be broken by the minimum force given in table 2 applied as push or pull in the direction of the needle axis. Table 2 ­ Force to test bond bptween needle Nominal outside diameter of needle tube Force min. 40 >40 0 -4 +1,5 -2,s hub and 11.3 Freedom from defects When examined by normal or corrected vision, the needle tube shall appear straight and of regular cross-section and wall thickness. 11.4 Lubricant mm N If the hypodermic needle tube is lubricated, the lubricant shall not be visible, under normal or corrected vision, as droplets of fluid on the outside or inside surfaces of the needle tube. NOTE t An acceptable lubricant, applied undiluted, is polydimethylsiloxane complying with a national or the European pharmacopoeia. The quantity of lubricant used should not exceed 0,25 mg per square centimetre of the surface area of the needle tube. 12 Needle point 0,3 0,33 0,36 0,4 0,45 0,5 0,55 0,6 0,7 0,8 0,9 1,1 1,2 22 22 22 22 22 22 34 34 40 44 54 69 69 When examined under x 2,5 magnification, the needle point shall appear sharp and free from feather edges, burrs and hooks. NOTE2 The needle point usually has a bevel with a primary bevel angle of (11 + 2)0 (as illustrated in figure2), but a "short" bevel with other angle, e.g. (17 + 2)0, maybe provided. The designation of needle point dimensions and the nomenclature used to describe the dimensions and features is shown for information in figure 2. The 13.2 Patency of lumen The patency of the lumen shall be such that either a) a stainless steel stylet of the appropriate diameter selected from the diameters given in table 3 shall pass through the needle; or b) the rate of flow of water through the needle under a hydrostatic pressure not exceeding 4 IS 10654:2002 ISO 7864:1993 1 x 105 Pazl shall be not less than 80 8/. of that of a needle of equivalent outside diameter and length having a minimum inside diameter in accordance with ISO 9626 when tested under the same pressure. d) that once opened, the container cannot be easily resealed, and it should be obvious that the con-tainer has been opened. 14.2 Secondary container -, ...-,- ­. ­. ,-. .-- 1.­. ----.. --... --., .. ---. -- Extensions In rn!llimetres One or more primary containers shall be packaged in a secondary container, The secondary container should be sufficiently robust to protect the contents during handling, transit and storage. One or more secondary containers may be packaged in a storage and/or a transit container. Diameter Nominal outside diameter of needie of stylet 0 -0,01 for needie of normalwalled tubing for needie of thin-walled tubing for needie of extra-thinwalied tubing 0,3 0,33 0,36 0,4 0,45 0,5 0,55 0,6 0,7 0,8 0,9 I,t 1,2 0,11 0,11 0,11 0,15 0,18 0(18 0,22 0,25 0,30 0,40 0,48 0,58 0,7.0 0,13 0,15 0,15 0,19 0,23 0,23 0,27 0,29 0,35 0,42 0,49 0,60 0,73 -- -- -- -- -- -- . 0,30 0,37 0,44 0,50 0,68 0,83 15 15.1 Labelling Primary container The Drimarv container shall be marked with at least the followin-g information: a) a description of the contents, including the designated metric size in accordance with clause 7; b) the word "STERILE"; c) the lot number, prefixed by the word "LOT"; d) the name or trade-mark or trade-name of the manufacturer or supplier. 15.2 Secondary container or logo 14 14.1 Packaging Primary container The secondary container shall be marked with at least the following information: a) a description of the contents, including the designated metric size in accordance with clause 7, the number, the type or angle of bevel (see clause 12) and, if appropriate, the words "thinwalled" or "extra-thin-walled" or equivalent or an abbreviation; b) the word "STERILE"; c) the words "FOR SINGLE USE" or equivalent (excepting the term "disposable"); NOTE3 The symbol given in annex C may additionally be given. d) a warning to check the integrity of each primary container before use; e) the lot number, prefixed by the word "LOT"; Each hypodermic needle shall be sealed in a primary container, The materiai and design of this container shall be such as to ensure that the colour coding of the contents is visible. The materials of the container should not have detrimental effects on the contents. The materials and design of this container should be such as to ensure a) the maintenance of sterility of the contents under dry, clean and adequately ventilated storage conditions; b) the minimum risk of contamination of the contents during removal from the container c) adequate protection of the contents normal handling, transit and storage; 2) 1 standard atmosphere (atm) = 101325 Pa 1 technical atmosphere (at) = 98066,5 Pa during IS 10654:2002 ISO 7864: 1993 f) the date (year and month expressed as specified in subclause 5.2.1.1 of ISO 8601:1988) of sterilization; NOTE4 The date of sterilization may be incorporated in the first several digits of the lot number. b) the lot number, prefixed by the word "LOT"; c) the word "STERILE"; d) the date of sterilization as specified in 15.2 9; e) the name and address of the manufacturer supplien f) or g) the name and address of the manufacturer supplier; h) information tation. 15.3 Storage or for handling, storage and transpor- information for handling, storage and transportation of the contents. container 15.4 If secondary containers are packaged in a storage container, the storage container shall be marked with at least the following information: a) a description 15.2 a); of the contents as specified in Transport wrapping If a storage container is not used but the secondary containers are wrapped for transportation, the information required by 15.3 shall either be marked on the wrapping or shall be visible through the wrapping. 6 IS ISO 10654:2002 7864: 1993 Annex A (normative) Method for preparation A.1 Principle A.3 of extracts Procedure The needle, including the inside of the needle tube, is immersed in water in order to extract soluble components. A.2 A.2.1 Apparatus Freshly and reagents or deionized water, distilled of grade 3 in accordance with ISO 3696. A,2.2 ware. Selection of laboratory borosilicate glass- A.3.1 Immerse 25 needles in 250 ml of water (A.2.1) in a suitable container made from borosilicate glass (A.2.2). Ensure that all surfaces of the needles, including the inside of the needle tube, are in contact with the water. Maintain the water at a temperature of (37 `~) "C for (60 + 2) min. Remove the needles and ensure that all water from the inside and outside surfaces of the needles is returned to the container. A.3.2 Prepare the control fluid by following the procedure given in A.3. I but omitting the needles. 7 IS ISO 10654:2002 7864: 1993 Annex B (informative) Example B.1 of method for determination of fragment production from rubber closures Principle B.2,8 Distilled or deionized water, of grade 3 in accordance with ISO 3696. Penetration of ISO rubber closures for injection vials by the needle, and collection and counting of the fragments generated by the penetrations, Because the number of fragments generated is affected by variables of needle desian, each ty~e of needle to be tested is compared ~ith the p-erformance of a reference needle. B.3 Procedure B.3.I Place n ml of water (B.2,8) into the vial (B.2.1), where n is 50 % of the nominal capacity of the vial. B.2 Apparatus and reagents 6.2.1 Injection vials, in accordance with ISO 8362-1 or ISO 8362-4. B.3.2 Place a closure (8.2.2) on the vial and seal with an aluminium cap (B.2.3) using the handoperated capping device (B.2.4). Inspect the vial by normal or Corrected-to-normal vision for the presence of fragments, and discard any vial in which rubber fragments are visible. B.2.2 Rubber closures, in accordance with ISO 8362-2, as follows: Type A, nominal size 20 Hardness: 40 IRHD Base elastomer: Halogenated butyl. 6.3.3 Fill the syringe (B.2.6) with water (B.2.8). Attach a reference needle to the syringe and remove any water from the outside of the needle tube. B.3.4 Place the vial vertically and, holding the syringe vertically, pierce the closure. caps, in accordance with B.2.3 Aiuminium ISO 8362-3, having a central hole, to fit the injection vials (B.2.1). B.3.5 Inject 2 ml of water into the vial, and withdraw the needle from the vial. Remove the needle from the syringe and replace it with a fresh reference needle. Remove any water from the outside of the needle tube. B.2.4 Hand-operated capping device, suitable for vials (B.2.1) and caps (B.2.3). B.3.6 Repeat B.3.4 and B.3.5 for a total of five penetrations, choosing a different area of the closure each time. B,2.5 Membrane filter, of pore size 5 }lm, and filter holder. 6,2,6 Hypodermic syringe, of 10 ml nominal pacity in accordance with ISO 7886-1. ca- B.3.7 Repeat B.3.3 to 6.3.6 on a total of five vials, i.e. 25 reference needles and 25 penetrations in all. 6,2.7 Reference needles, of the same nominal outside diameter of the type of needle to be tested, and having a nominal value of a (see figure2) of 13°, B.3.8 Repeat B.3.3 to 6.3.7, using 25 needles of the type to be tested. 8 IS ISO 10654:2002 7864:1993 B.3.9 Remove the closure from the five vials from B.3.7 and filter the contents through the membrane filter (B,2.5). Ensure that no fragments remain in the vial. B.3.1O a) the number of fragments generated by the reference needles, as counted in B.3.1 I; b) the number of fragments generated by the type of needle tested, as counted in B.3,11; c) the date of testing Repeat B.3.9 on the five vials from 6.3.8, using a second membrane filter. B.3.11 Count and record the number of fragments on each filter visible with normal or corrected vision without magnification, the distance between the eye and the filter being (250 ~ 5) mm. B.5 Validity B.4 Test report ` The test reporf shall contain at least the following information: Consider the results obtained from the test needles to be invalid if the results from the reference needles lack consistency with previous results. Determine the reasons for the inconsistency. IS 10654:2002 7864:1993 ISO Annex C (informative) Symbol for "do not re-use" C.1 General the circle (dimension 1,16 a, i.e. 58 mm. h) of the original design is The ISO symbol to denote equipment intended for single use is ISO symbol registration number ISO 7000/1051, given in ISO 7000:1989. NOTE5 Further information on design, dimensions and application of ISO symbols is given in ISO 3461. No colour is specified in ISO 7000 or in this international Standard for symbol 1051. C.3 Reduction original design and enlargement of C.2 Original design Symbol ISO 7000/1051 is shown in figure Cl. The thickness of the lines is 2 mm. Dimension a is the nominal size of the original design of all ISO symbols and is normally made equal to 50 mm. In many cases, including ISO 7000/1051, the actual dimension differs slightly, and the outside diameter of For the application of the symbol it may be necessary to reduce or enlarge the size of the original to a suitable size at which it will actually appear. The nominal dimension a should be used as a gauge. Practice has shown that a may be reduced to 3 mm without the symbol losing its legibility. However, the legibility of the symbol when reduced in size should be checked. r 7 L h=l,ltia -1 ISO symbol for "do not re-use", number ISO 7000/1051 NOTE­ The visual centring lines do not form part of the symbol. Figure C.1 ­ 10 IS ISO 10654:2002 7864:1993 Annex D (informative) Bibliography [1] 1S0595-1 :1986, Reusable a//-assss or rneta/and-glass syringes for medical use -- Part 1: Dimensions. ISO 595-2:1987, Reusable a/1-glass or meta/and-glass syringes for medical use -- Part 2: Design, performance requirements and tests. ISO 3461-1:1988, Genera/ principles for the creation of graphical symbols -- Part 1: Graphical symbols for use on equipment. ISO 3461-2:1987, Genera/ principles for the creation of graphica/ symbo/s -- Part 2." Graphical symbols for use in technical product documentation. ISO 7000:1989, Graphica/ symbols equipment -- Index and synopsis. for use on [6] ISO 8362-1:1989, Injection containers for injectable and accessories -- Part 1: Injection vials made of glass tubing. ISO 8362-2:1988, Injection containers for injectable and accessories -- Part 2." Closures for injection vials. ISO 8362-3:1989, Injection containers for injectable and accessories -- Part 3: Aluminium caps for injection vials. [2] [7] [3] [8] [4] [9] ISO 8362-4:1989, h?jection containers for injectable and accessories -- Part 4: Injection vials made of moulded glass. [10] ISO 8537:1991, Sterile sing/e-use syringes, or without needle, for insulin. with [5] [11] ISO 10993-1:1992, Bio/ogica/ evacuation of medical devices -- Part 1: Guidance on seIec(ion of tests. 11 (Continued from second cover) In this adopted standard, reference appears to the following International Standard for which Indian Standard also exists. The corresponding Indian Standard which is to be substituted in its place is listed below along with its degree of equivalence for the edition indicated: International Standard ISO 594-1:1986 Corresponding Indian Standard IS 3234 (Part 1):1986 Conical fittings with a 6 percent (Luer) taper for syringes, needles and Part 1 General other medical equipment: requirements (second revision) Degree of Equivalence Identical The technical committee responsible for the preparation of this standard has reviewed the provisions of ISO 594-2, ISO 3696, ISO 6009, ISO 7866-1, ISO 8601 and ISO 9626, referred in this adopted standard, and has decided that they are acceptable for use in conjunction with this standard. For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test, shall be rounded off in accordance with IS 2 : 1960 `Rules for rounding off numerical values (revised)'. 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